Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer (LPM-012)

Lightpoint Medical

Status: Unknown

Conditions: Prostate Cancer

Treatments: Device: SENSEI®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04632251

LPM-012

Details and patient eligibility

About

This study is a prospective, open label, single-arm study to examine the performance and safety of the SENSEI® laparoscopic tethered gamma probe in patients undergoing 99mTc-nanocolloid SLNB for prostate cancer (PCa) during RP and ePLND surgery.

Patients scheduled for RP and ePLND using the standard treatment pathways at each centre will have preoperative 99mTc-nanocolloid imaging. RP and ePLND will be conducted as standard of care, with SLNB guided by the SENSEI® laparoscopic tethered gamma probe carried out after RP and prior to ePLND. The first 2 patients per site (N = 10 in total) are considered to be sufficient to enable further familiarisation with the procedure and use of the probe in addition to the usability work and training that the sites did prior to the start of this study. Subsequent patients will be evaluable for the PP population. The primary analysis of diagnostic performance will be performed using the PP population of patients with SLN identified on preoperative imaging

Enrollment: 56 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male subjects who are ≥ 18 years of age with histologically proven prostate cancer; and who have signed an informed consent form prior to any study related activity • Subjects who are scheduled for radical prostatectomy with ePLND.

Exclusion criteria

• Subjects who have received prior prostate cancer treatment or prior pelvic surgery;

  • Subjects who have an existing medical condition that would compromise their participation in the study;
  • Subjects with a history of hypersensitivity to 99mTc-nanocolloid or any excipients;
  • Subjects who are unable to give voluntary, written informed consent to participate in this study;
  • Subjects who are unable to understand this study and are not willing to complete all the study assessments.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Familiarisation

Other group

Description:

The first 2 patients per site (N = 10 in total) are considered to be sufficient to enable further familiarisation with the procedure and use of the probe in addition to the usability work and training that the sites did prior to the start of this study.

Treatment:

Device: SENSEI®